Thrombectomy catheter systems

ABSTRACT

A thrombectomy catheter system is disclosed which includes a catheter having an exhaust lumen, an infusion lumen and a high pressure tube. The high pressure tube includes a nozzle orifice for forming a high pressure jet of fluid for cutting occlusive material from within a body lumen. The nozzle orifice is positioned to direct the high pressure jet of fluid into the distal end of the exhaust lumen which creates a suctioning effect. The infusion lumen replaces fluid that is removed from the body lumen through the exhaust lumen by a suctioning effect created by the fluid jet.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 13/630,323, filed Sep. 28, 2012, which claims the benefit ofand priority to U.S. Provisional Application Ser. No. 61/591,165, filedJan. 26, 2012, the entire contents of applications Ser. No. 13/630,323and 61/591,165 are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to systems for removing occlusivematerials from within blood vessels, and more particularly, tothrombectomy catheter systems.

BACKGROUND

Apparatus for removing occlusive material from a body lumen to maintainthe patency of the body lumen are well known in the art. These apparatusmay be of the mechanical, electrical or chemical type. Typically, eachtype of apparatus is particularly suited for removal of a particulartype of occlusive material from the body lumen such as chronic clots,sub-acute clots or acute clots. For example, apparatus which infusechemicals into a body lumen to remove occlusive material from the lumenare more effective in removing acute clots and are less effective inremoving chronic clots.

One difficulty associated with designing an apparatus for removing alltypes of occlusive material from a body lumen is creating a device thatcan effectively remove occlusive material while at the same timeminimizing the likelihood of causing damage to the body lumen.

Accordingly, it would be desireable to provide an apparatus capable ofeffectively removing a variety of different occlusive materials from abody lumen while minimizing the risk of causing damage to the bodylumen.

SUMMARY

The present disclosure is directed to a thrombectomy catheter systemwhich includes a thrombectomy catheter including a catheter bodydefining an exhaust lumen and an infusion lumen and including a highpressure tube. In one aspect, the high pressure tube has a nozzleorifice positioned to direct a fluid jet into a distal opening of theexhaust lumen. A source of infusion fluid communicates with a proximalend of the infusion lumen and a fluid control device is fluidly coupledbetween the thrombectomy catheter and the source of infusion fluid. Thefluid control device is adapted to regulate a flow rate of infusionfluid from the source of infusion fluid to the infusion lumen of thethrombectomy catheter.

In one embodiment of the thrombectomy catheter system, the infusionfluid and fluid in the high pressure tube is saline.

In another embodiment, the thrombectomy catheter system includes a highpressure tube which defines a bent portion at the distal end of the highpressure tube. The nozzle orifice is positioned in the bent portionwhich extends along an axis which is substantially transverse to alongitudinally axis of the thrombectomy catheter.

In another embodiment, the thrombectomy catheter system includes asource of high pressure fluid communicating with the high pressure tube.The source of high pressure fluid supplies high pressure fluid to thehigh pressure tube at a pressure of between about 100 psi and about10,000 psi.

In another embodiment, the thrombectomy catheter system includes asubstantially rigid positioning band secured to a distal end of thecatheter body. The positioning band defines an exhaust lumen whichcommunicates with the exhaust lumen of the catheter body and an infusionlumen which communicates with the infusion lumen of the catheter body.

In one embodiment, the high pressure tube is bonded to the positioningband. The high pressure tube and the positioning band may be formed ofeither metal or plastic.

In one embodiment, the high pressure tube extends through the infusionlumen of the positioning band and the catheter body.

In one embodiment, the infusion lumen of the positioning band defines apair of concavities dimensioned to receive the high pressure tube andprevent lateral movement of the high pressure tube in relation to thepositioning band.

In one embodiment, the infusion lumen in the positioning band isadjacent to the exhaust lumen of the positioning band, and covers an arcangle of at least 140°.

In another embodiment, a fluid control device is provided which includesan adjustable valve adapted to regulate the fluid flow rate into theinfusion lumen of the thrombectomy catheter from the source of infusionfluid.

In one embodiment, the fluid control device includes a fluid pump forsupplying infusion fluid to the thrombectomy catheter from the source ofinfusion fluid. The fluid pump or the adjustable valve may be adapted tovary the flow rate of infusion fluid to the thrombectomy cathetercyclically.

In another embodiment, the thrombectomy catheter includes an atraumatictip which includes a pair of infusion channels which communicate withthe infusion lumen of the positioning band and a reservoir for receivingthe bent portion of the high pressure tube. The reservoir has an upperopening defining a cutting window.

In another embodiment, the infusion channels extend distally of the bentportion of the high pressure tube and enable the longitudinal ortransverse infusion of infusion fluid at the tip.

In another embodiment, the atraumatic tip has microchannels to enablefluidic coupling between the central cavity and the infusion channels.The microchannels are either orifices in the wall separating the centralcavity and the infusion channels or are open channels formed bydepressions on the surface of the atraumatic tip.

In another embodiment, the thrombectomy catheter system includes a guidecatheter defining a guide lumen dimensioned to receive the thrombectomycatheter, a proximal balloon, and a distal balloon.

In another embodiment, a portion of the guide catheter between theproximal balloon and the distal balloon has a sinusoidal shape anddefines a plurality of openings which enable the aspiration of occlusivematerial into the thrombectomy catheter.

In yet another embodiment, the thrombectomy catheter system may includea portion of the guide catheter between the proximal balloon and thedistal balloon that is flexible and defines a plurality of openingswhich enable the aspiration of occlusive material from the vessel intocontact with the thrombectomy catheter. The flexibility of the portionof the guide catheter is such that a sinusoidal shape imparted to thethrombectomy catheter is taken by the guide catheter once thethrombectomy catheter is inserted into the guide catheter such that theguide catheter is then sinusoidal in shape.

In one embodiment, a sensor is positioned to measure the pressure withina body lumen. The sensor may be connected to the fluid control device tocontrol operation of the fluid control device.

In one embodiment, a recirculation channel is positioned to recirculatefluid from within the exhaust lumen back into a body lumen. A filter maybe positioned upstream of the recirculation channel which is sized toprevent passage of solid particles into the recirculation channel.

In one embodiment, the exhaust lumen is divided into a first exhaustlumen and a second exhaust lumen by a dividing wall and the filter andrecirculation channel are positioned in the first exhaust lumen. Thefilter may be positioned at one end of the first exhaust lumen andangled to direct solid particles into the second exhaust lumen.

In one embodiment, a recirculation channel is provided which extendsbetween the exhaust lumen and the high pressure tube. A filter may beprovided in the recirculation channel which enables small solidparticles to enter the high pressure tube to create a sand blastingeffect adjacent the nozzle orifice.

In one embodiment, structure configured to break up occlusive materialis positioned within the exhaust lumen. The structure may include agrate having sharp cutting edges. Alternately, the structure may includea rotatable turbine configured to grind occlusive material.

In one embodiment, the thrombectomy catheter includes a body defining awindow between the nozzle orifice and an inlet to the exhaust lumen, anda cage is positioned adjacent the window to cover the window.

The device described herein can be implemented to realize one or more ofthe following advantages. The thrombectomy catheter employs a highpressure waterjet for removing occlusive materials from within bloodvessels, which may be safer than mechanical cutting devices. Thepresently disclosed thrombectomy catheter systems are particularlysuited for treatment and removal of various clots, such as deep venousthrombosis (DVT), no matter the age or organization of the thrombosis orclot. For example, the thrombectomy catheter may remove both acute andchronic clot. The disclosed thrombectomy catheter may be configured invarious ways to protect the body lumen while enabling the waterjet toremove the clot. The body lumen may be protected by specific structurepositioned adjacent the waterjet that provides a physical barrieragainst cutting the body lumen. Further, the body lumen may be protectedby monitoring the pressure in the body lumen adjacent to the waterjet tosignal a controller to stop cutting (i.e., turn the waterjet off) or toinfuse fluid into the body lumen.

Also, the disclosed thrombectomy catheter provides an infusion liquid toprovide fluid balance within the body lumen to prevent the body lumenfrom being excessively drained of blood and fluid.

Further, a separate means for transporting the clot out of the bodylumen through the thrombectomy catheter is not required since the highpressure fluid provides the necessary motive force to move the clotthrough the thrombectomy catheter. Further still, the disclosedthrombectomy catheter may be provided with a means to macerate theremoved clot to better transfer the clot through the thrombectomycatheter. The means to macerate the clot may return some of the smallerparticles of the macerated clot back into the fluid stream to helpfurther break up the clot.

Other features and advantages of the disclosure are apparent from thefollowing description, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed thrombectomy cathetersystem are described herein with reference to the drawings, wherein:

FIG. 1 is a schematic view of one embodiment of the presently disclosedthrombectomy catheter system;

FIG. 1A is a graph illustrating the infusion fluid flow rate per unit oftime for one embodiment of the presently disclosed system;

FIG. 1B is a graph illustrating the infusion fluid flow rate per unit oftime for another embodiment of the presently disclosed system;

FIG. 2 is a side, perspective view of the distal portion of oneembodiment of the presently disclosed thrombectomy catheter of thesystem shown in FIG. 1;

FIG. 2A is a perspective view of the distal end of the catheter bodyshown in FIG. 2 with the distal end of the high pressure tube cutaway;

FIG. 3A is a front perspective view of a positioning band of thethrombectomy catheter shown in FIG. 2;

FIG. 3B is a rear perspective view of the positioning band shown in FIG.3A;

FIG. 4 is a side perspective view of the distal portion of analternative embodiment of the presently disclosed thrombectomy catheter;

FIG. 5 is a side cross-sectional view of the thrombectomy catheter shownin FIG. 4;

FIG. 6 is a perspective, cross-sectional view taken along section lines6-6 of FIG. 4;

FIG. 7 is a perspective view of the distal end of the catheter body andcatheter tip of the thrombectomy catheter shown in FIG. 4;

FIG. 8 is a side view of the catheter body and catheter tip shown inFIG. 4;

FIG. 9 is a front view of the thrombectomy catheter shown in FIG. 4;

FIG. 10 is a side schematic view of an alternate embodiment of thepresently disclosed thrombectomy catheter system including athrombectomy catheter and a guide catheter;

FIG. 11 is an enlarged view of the indicated areas of detail shown inFIG. 10; and

FIG. 12 is a cross-sectional view taken along section lines 12-12 ofFIG. 11.

FIG. 13 is a side view of an alternate embodiment of the presentlydisclosed thrombectomy catheter;

FIG. 14 is a side view of yet another embodiment of the presentlydisclosed thrombectomy catheter;

FIG. 15 is a side cross-sectional view of a distal end of anotherembodiment of the presently disclosed thrombectomy catheter;

FIG. 16 is a cross-sectional view taken along section lines 16-16 ofFIG. 15;

FIG. 17 is a side cross-sectional view of a distal end of anotherembodiment of the presently disclosed thrombectomy catheter;

FIG. 18 is a cross-sectional view taken along section lines 18-18 ofFIG. 17;

FIG. 19 is a side cross-sectional view of another embodiment of thepresently disclosed thrombectomy catheter;

FIG. 20 is a side cross-sectional view of yet another embodiment of thepresently disclosed thrombectomy catheter;

FIG. 21 is a side cross-sectional view of another embodiment of thepresently disclosed thrombectomy catheter; and

FIG. 22 is a side cross-sectional view of yet another embodiment of thepresently disclosed thrombectomy catheter.

DETAILED DESCRIPTION OF EMBODIMENTS

Embodiments of the presently disclosed thrombectomy catheter system willnow be described in detail with reference to the drawings wherein likereference numerals identify similar or identical elements in each of theseveral views. As used herein, the term “distal” refers to that portionof the presently disclosed thrombectomy catheter system, or componentthereof, that is furthest from the user, such as a physician, duringproper use, while the term “proximal” refers to that portion of thethrombectomy catheter system, or component thereof, that is closest tothe user during proper use. Additionally, the term “lumen” should beunderstood to include any lumen within the body, either natural orartificial, such as, for example, blood vessels, blood vessel grafts,fistulas, and the like. Moreover, the term “occlusion” should beunderstood to encompass any partial or total blockage of a lumen, suchas, for example, thrombus, atheromas, plaque, tumors and the like.

FIG. 1 is a schematic view of one embodiment of the presently disclosedthrombectomy catheter system which is shown generally as 10.Thrombectomy catheter system 10 includes a thrombectomy catheter 12, asource of infusion fluid 14, a source of high pressure fluid 16, and areservoir 18 for receiving fluid exhausted from the surgical site. Eachof the sources of infusion fluid 14 and high pressure fluid 16, and theexhaust fluid reservoir 18, communicate with the thrombectomy catheter12 via a suitable fluid conduit 20 a-20 c, respectively. A controldevice 22 may be provided in the fluid conduit 20 a connecting theinfusion fluid source 14 to the thrombectomy catheter 12. The controldevice 22 may include a pump or valve which is operable to regulate theflow rate of infusion fluid to the thrombectomy catheter 12, as will bediscussed in further detail below.

Referring to FIGS. 2-3B, thrombectomy catheter 12 includes a catheterbody 24, a positioning band 26 and a high pressure tube 28. Catheterbody 24 of catheter 12 defines at least two lumens and may be formed,such as by extrusion, from any suitable biocompatible materialsufficiently pliable to facilitate insertion of the catheter 12 into abody lumen. Suitable materials include, but are not limited to,polymeric materials, elastomeric materials, for example, silicone andfabric materials, or a synthetic resin, for example, polyurethane,polyethylene, polypropylene, nylons, polytetrafluoroethylene (PTFE),polyether ether ketone (PEEK), PEBAX®, or polyimide. In one embodiment,catheter body 24 defines an exhaust lumen 30 and an infusion lumen 32(see FIG. 2A). The exhaust lumen 30 defines a lumen to exhaust fluid andincludes a proximal end which is in fluid communication with fluidconduit 20 c (FIG. 1) and exhaust fluid reservoir 18. The infusion lumen32 defines a lumen to infuse fluid and is in fluid communication withthe fluid conduit 20 a (FIG. 1) and the infusion fluid source 14.Although exhaust lumen 30 is illustrated to be circular and infusionlumen 32 is illustrated to be crescent shaped, a variety of otherconfigurations are envisioned for the exhaust and infusion lumens 30 and32.

Positioning band 26 is supported on the distal end of the catheter body24 and defines exhaust and infusion lumens 30 a and 32 a whichcommunicate with exhaust and infusion lumens 30 and 32, respectively, ofcatheter body 24. Positioning band 26 includes a first proximalextension 34 which has a shape which corresponds to the shape of exhaustlumen 30 of catheter body 24 and a second proximal extension 36 whichhas a shape that corresponds to the shape of the infusion lumen 32 ofthe catheter body 24. The proximal extensions 34 and 36 are receivablein the distal ends of exhaust and infusion lumens 30 and 32 of catheterbody 24 to frictionally secure the positioning band 26 to the distal endof catheter body 24. Alternatively, or in addition to frictionalengagement, the positioning band 26 may be secured to the distal end ofcatheter body 24 by other fastening techniques including usingadhesives, welding, crimping or the like. In one embodiment, theinfusion lumen 32 a in the positioning band 26 is adjacent to theexhaust lumen 30 a of the positioning band 26, and may have an area thatextends for an arc angle θ greater than about 140° and preferablygreater than 180°. See FIG. 18. The positioning band 26 may be formedfrom a suitable biocompatible plastic including polymeric materials,including thermoplastics or the like, or a suitable biocompatible metal,including stainless steel, titanium or the like.

The high pressure tube 28 is positioned to extend through the infusionlumen 32 and includes a closed distal end and a bent portion 40 defininga nozzle orifice 40 a (see FIG. 5). As illustrated, the bent portion 40is positioned transversely to the longitudinal axis of catheter body 24such that the nozzle orifice 40 a is positioned to direct a jet 50 offluid in a direction substantially parallel to the longitudinal axis ofthe catheter 12 into the exhaust lumen 30 a of the positioning band 26.Although bent portion 40 is shown to be about 90 degrees offset from thelongitudinal axis of the catheter body 24, it is envisioned that bentportion 40 may be bent about 180 degrees and the nozzle orifice 40 a canbe formed in the distal end of the high pressure tube 28. In oneembodiment, the high pressure tube 28 is formed from a metal, such asNitinol or stainless steel. Alternatively, the high pressure tube 28 maybe formed from a thermoplastic material such as a polyether ether ketone(PEEK). The high pressure tube 28 may be secured or bonded to thepositioning band 26 using, for example, adhesives, welding or the like,to ensure that nozzle orifice 40 a of tube 28 is properly positioned inrelation to exhaust lumen 30 a of positioning band 26 as will bediscussed in further detail below. Alternatively, the high pressure tube28 may be slidably positioned in relation to the exhaust lumen 30 a ofpositioning band 26 to enable the spacing between the nozzle orifice 40a and the exhaust lumen 30 a to be selectively varied. In oneembodiment, the positioning band 26 includes upper and lower concavities46a and 46b (FIG. 3A) which are dimensioned to receive the high pressuretube 28 and to minimize lateral movement of tube 28 in relation to band26.

As discussed above, the nozzle orifice 40 a may be spaced distally ofexhaust lumen 30 a of positioning band 26 a predetermined distance. Thenozzle orifice 40 a may be cylindrical in shape to produce asubstantially symmetrical conical jet (see FIG. 2). In one embodiment,the diameter of nozzle orifice 40 a is between about 0.001 to 0.01 inch.Alternatively, the nozzle orifice 40 a may be conical with the inletopening of the nozzle orifice 40 a having a larger diameter than theexhaust opening of the nozzle orifice 40 a. Such a conical nozzleorifice is better suited for use with lower fluid pressures. Asdiscussed above and shown in FIG. 2, the fluid jet 50 produced by thenozzle orifice 40 a is configured to be received entirely within theexhaust lumen 30 a of the positioning band 26.

In one embodiment of the presently disclosed thrombectomy catheter 12,the diameter of the exhaust lumen 30 a is about 0.050 inch, the diameterof the cylindrical jet nozzle 40 a is about 0.005 inch and the spacingbetween nozzle orifice 40 a and exhaust lumen 30 a is about 0.008 inch.Alternatively, the spacing between nozzle orifice 40 a and exhaust lumen30 a is about 0.060 inches. Alternately, other dimensions may beselected to optimize aspiration of fluid flow through the exhaust lumens30 a and 30 of catheter 12.

Referring to FIGS. 1 and 2, when thrombectomy catheter system 10 is usedto remove occlusive materials from within a blood vessel, thethrombectomy catheter 12 is positioned within the venous system of apatient using standard percutaneous access techniques. Although notshown, catheter body 24 and positioning band 26 may be formed to includea guidewire bore to assist in placement of catheter 12 within a vessellumen of a patient. Alternatively, a guidewire may be passed down theinfusion lumen 32 to effect placement of the catheter 12. With thecatheter 12 positioned within a vessel lumen, the catheter 12 isadvanced to position the distal end of catheter 12 within or in abutmentwith the occlusive material. Pressurized fluid, such as saline or water,is then supplied at a pressure of from about 100 psi to about 10,000 psifrom high pressure fluid source 16 through fluid conduit 20 b to thehigh pressure tube 28. Alternatively, a thrombolytic agent such as tPAmay be mixed in with the pressurized fluid. The high pressure fluidtravels through high pressure tube 28 and exits nozzle orifice 40 a(FIG. 5) as a high pressure fluid jet 50. As the high pressure fluid jet50 passes into exhaust lumen 30 a of positioning band 26, the fluid jet50 causes entrainment of surrounding fluid and occlusive material intothe jet in the proximity of the exhaust lumen 30 a. Depending on thevarious parameters disclosed, a vacuum is created and may be in therange of 10-760 mmHg. When this occurs, occlusive material is drawn intocontact with the high pressure fluid jet 50 and is cut. The occlusivematerial which has been cut, and fluid within the vessel lumen such asblood, is evacuated from the vessel lumen into the exhaust lumen 30 a,30 of the catheter body 24 where it flows proximally from catheter 12 toconduit 20 c and into exhaust fluid reservoir 18.

In order to replace the fluid which is removed from the vessel lumen asa result of the suctioning effect created by the high pressure fluid jet50 within the vessel lumen, fluid is supplied or infused into the vessellumen from infusion fluid source 14 through infusion lumen 32 ofcatheter body 24. The infusion lumen 32 may also be used to introduce athrombolytic agent or contrast medium into a vessel lumen as describedbelow. In one embodiment, the infusion fluid, which may be saline, ispassively drawn into the infusion lumen 32 by the negative pressurecreated in the vessel lumen adjacent the distal end of the infusionlumen 32 by the high pressure jet 50. In such an embodiment, the controldevice 22 which may be positioned in the fluid conduit 20 a connectingthe infusion fluid source 14 to the catheter 12, may include anadjustable valve which can be selectively operated to control theinfusion fluid flow rate to the catheter 12. In such an embodiment, theflow rate of fluid supplied to the infusion lumen 32 of catheter 12 maybe cylically varied by the adjustable valve to assist in breaking up theocclusive material. Specifically, the pulsation of fluid caused bycyclically varying the flow rate of the fluid supplied through theinfusion lumen 32 may help to disrupt or break up the occlusivematerial. In other passive embodiments, a control device 22 may not bepresent, and the fluid within the infusion fluid source 14 may be freelymoved by the vacuum created within the vessel lumen.

In an alternative embodiment, the control device 22 may include a pump,such as a gear pump or peristaltic pump, to provide a pressurized flowof infusion fluid to the infusion lumen 32 of catheter 12. In such anembodiment, the flow rate of fluid supplied to the infusion lumen 32 ofcatheter 12 may be cyclically varied to assist in breaking up theocclusive material as discussed above. Cyclically varying the flow rateof the fluid supplied to the infusion lumen 32 of the catheter 12 overtime may also minimize the likelihood of a wall of the vessel lumenbeing drawn into contact with the high pressure jet 50. The cyclicalvariation of the flow rate may be in the form of a square wave orsinusoidal wave as shown in FIGS. 1A-1B, and may have a frequency in therange of 0.5 to 2.0 Hz.

Referring to FIG. 1, a restrictor 23 may be provided in fluid conduit 20c connecting the exhaust lumen 30 of the catheter 12 to the exhaustfluid reservoir 18. The restrictor 23 may include a mechanical devicefor compressing or crimping the fluid conduit 20 c. Alternatively, othervariable restrictor devices may be incorporated into fluid conduit 20 c.The restrictor 23 functions to selectively vary the amount of fluidaspirated due to entrainment created by the high pressure fluid jet 50and thus may enable control of the vacuum created at the distal end ofthe exhaust lumen 30. In one embodiment, the restrictor 23 may beselectively operated to periodically change the restriction over time.Alternately, a flow meter (not shown) may be provided to measure thefluid flow rate of fluid being aspirated in fluid conduit 20C attachedto the reservoir 18 and the restrictor 23 can be operated to control thefluid flow rate in the exhaust lumen 30 to match the fluid flow rate inthe infusion lumen 32.

In one embodiment, a pressure sensor is integrated into the thrombectomycatheter to assist in balancing the volume of fluid aspirated from abody lumen with the volume of fluid infused into the body lumen.Referring again to FIG. 2, one or more sensors 80 a-c may be positionedat a variety of locations on the thrombectomy catheter 12, including onthe high pressure tube 28 (80 c), on the front face of the positioningband 26 (80 b), and/or on the outer surface of the positioning band 26(80 a). Alternatively, the sensors may be positioned at other externalor internal locations on the thrombectomy catheter 12. In oneembodiment, the sensors are low profile fiber optic sensors such asthose manufactured by Fiso Technologies, Inc. or Opsens, Inc.Alternately, other types of pressure sensors may be used to measure thepressure within a body lumen being treated by a thrombectomy catheter.The location of the sensor should be selected to provide an accuratemeasurement of the pressure within the body lumen, not the pressureimmediately adjacent the distal end of the catheter 12. As such, thebest place for sensor placement may be a location spaced from the distalend of the exhaust lumen 30 a, 30, particularly a location that isshielded from the fluid flow into and out of the catheter 12.

Alternatively, a sensor 80 may be positioned within a lumen of thecatheter 12 (not shown), or on accessories of the catheter such as on aguidewire or a separate guide catheter. In addition, a separate pressuremonitoring lumen (not shown) may be provided in the catheter 12 whichcommunicates with the body lumen and communicates with a strain gauge orthe like externally of the body to monitor the pressure of fluid withinthe body lumen. It is noted that if a sensor is positioned within anexisting lumen of the catheter 12 such as in the exhaust lumen 30, flowthrough the lumen must be stopped prior to taking a pressure measurementto obtain a reading which reflects the pressure within the body lumenand not the pressure within the exhaust lumen. In such an embodiment,the flow restrictor 23 may be used to cyclically stop flow to enableperiodic measurements of the pressure within the body lumen.

The purpose of providing a pressure sensor to measure pressure within abody lumen is to maintain balance between the volume of fluid removedfrom the body lumen through the exhaust lumen 30 and the volume of fluidinfused into the body lumen through infusion lumen 32. In use, prior tooperating the catheter 12, the lumen pressure is measured to establish abaseline pressure within the lumen. Thereafter, high pressure fluid issupplied through the high pressure tube 28 such that jet 50 passes intoexhaust lumen 30 a, 30. As the jet 50 passes into the exhaust lumen 30a, 30, a venturi effect is created which draws a vacuum around theexhaust lumen 30 a and within the body lumen such that fluid includingocclusive material is drawn into the exhaust lumen 30, 30 a. When thepressure sensor 80 senses that the pressure within the body lumen hasdropped below a threshold pressure, for example, 90% of the lumenbaseline pressure, a signal is provided to begin infusion throughinfusion lumen 32. When a second threshold pressure is reached, forexample, 105% of the baseline pressure, a signal is provided to stopinfusion. The process of starting and stopping infusion can beautomatically controlled using known fluid control devices.Alternatively, the sensors may be used to operate the control device 22or the restrictor 23 to balance fluid flow to and from the catheter 12.

Although the thrombectomy catheter 12 described above is best suited forremoval of acute to sub-acute occlusive material, catheter 12 is fullycapable of removing all types of occlusive material from within a vessellumen, including chronic clots. To remove all types of occlusivematerial from a vessel lumen, the distal end of the catheter 12 must bepushed into the occlusive material to enable the occlusive material tobe positioned adjacent the distal end of catheter 12 such that theocclusive material can be drawn into the jet 50, cut, and macerated.

Referring to FIGS. 4-8, in order to minimize the likelihood that avessel lumen may be damaged during insertion or manipulation of catheter12 into or within a vessel lumen, catheter 12 may be fitted with anatraumatic tip 60. Atraumatic tip 60 includes a body 62 having a heightand width which decrease from the proximal end of body 62 towards thedistal end of the body 62 such that the distal end defines a bluntsurface 64. Alternatively, the distal end of the body 62 may be morepointed to further enable the catheter 12 to enter the occlusivematerial. The body 62 also defines a central cavity 66, an upper openingor cutting window 68 for receiving occlusive material, and a pair ofinfusion channels 70 which communicate with the infusion lumen 32 a ofthe positioning band 26 and the infusion lumen 32 of catheter body 24.The infusion channels 70 may include an enclosed portion 70 a and anopen portion 70 b. Infusion channels 70 each may have a proximal end ofthe open portion 70 b generally longitudinally aligned with the nozzleorifice 40 a and a distal end extending distally of nozzle orifice 40 a.The distal opening of the infusion channels 70 in the atraumatic tip 60may be longitudinal (as shown in FIGS. 7-9) or transverse (not shown).

The atraumatic tip 60 is secured to the distal end of catheter body 24using any known fastening technique including adhesives, welding or thelike. When tip 60 is secured to the catheter body 24, the bent portion40 of high pressure tube 28 is positioned within central cavity 66 ofatraumatic tip 60 such that nozzle orifice 40 a is aligned with exhaustlumen 30 a of positioning band 26.

The atraumatic tip 60 provides several advantages to the presentlydisclosed thrombectomy catheter 12. More specifically, the taperedconfiguration of atraumatic tip 60 may assist in positioning the distalend of catheter 12 within the occlusive material to facilitatepositioning of the occlusive material within the high pressure jet 50.In addition, the configuration and positioning of infusion channels 70along sidewalls of atraumatic tip 60 at a longitudinal position adjacentto or distally of nozzle orifice 40 a may create a recirculation patternof fluid within the vessel lumen adjacent the atraumatic tip 60 of thecatheter which will assist in entry of the catheter 12 into toughocclusive material and removal of the occlusive material from the vessellumen. Further still, the tapered configuration of the atraumatic tip 60may further enable the occlusive material to enter into the cuttingwindow 68. Specifically, as the atraumatic tip 60 pushes into theocclusive material, and the occlusive material moves along the inclinedplane of the atraumatic tip 60, any resiliency in the occlusive materialwill push back against the atraumatic tip 60, and thus into the cuttingwindow 68.

In an alternative embodiment shown in phantom in FIG. 7, one or moremicrochannels 82 may be provided in body 62 of tip 60 between infusionchannels 70 and cavity 66. Microchannels 82 maintain a path for infusionfluid to flow between infusion lumen 32 of catheter body 24 and centralcavity 66 of atraumatic tip 60. In a situation where the atraumatic tip60 is positioned within the occlusive material such that channels 70 areobstructed, the microchannels 82 enable fluid to circulate within theatraumatic tip 60 between the infusion lumen 32, 32 a and the centralcavity 66. Alternatively, the microchannels 82 may be formed along anouter surface of the atraumatic tip 60, and extend between the infusionchannels 70 and the cutting window 68.

In another embodiment, the atraumatic tip 60 has microchannels 82 toenable fluidic coupling between central cavity 66 and the infusionchannels 70. The microchannels 82 are either orifices in the wallseparating the central cavity 66 and the infusion channels 70 or areopen channels formed by depressions on the surface of the atraumatic tip60 between the infusion channels 70 and the cutting window 68.

Referring to FIGS. 10-12, a guide catheter 100 may be used to assist inpositioning thrombectomy catheter 12 within a vessel lumen 102 (FIG.10). In one embodiment, the guide catheter 100 includes a guide catheterbody 104, a proximal balloon 106 and a distal balloon 108. The guidecatheter body 104 may be formed from nylons, polyurethanes, orelastomers such as Pebax®, and may include a reinforcing materials suchas stainless steel or Nitinol. The guide catheter body 104 defines aplurality of lumens including a guide lumen 110 dimensioned to receivethe thrombectomy catheter 12, an inflation lumen 112 forinflating/deflating the proximal balloon 106 and an inflation lumen 114for inflating/deflating the distal balloon 108. The guide catheter 100may be an appropriate size, such as, for example, a 10F or 12F catheter.Alternatively, a single inflation lumen may be provided for both theproximal and distal balloons 106 and 108. The guide catheter 100 mayalso define an additional lumen (not shown) for infusion of saline or athrombolytic agent, such as a tissue plasminogen activator (tPA),streptokinase, urokinase, or heparin, into the vessel lumen.

Referring to FIG. 10, at least a portion of the guide catheter 100between the proximal and distal balloons 106 and 108 includes asinusoidal shape 116. As shown, the sinusoidal shape 116 may extend theentire length of the guide catheter 100 between the proximal and distalballoons 106 and 108. In addition, the sinusoidal shape 116 may beformed by heat setting a PEEK material. Alternately, other methods offorming the sinusoidal shape 116 are envisioned. Alternately, asinusoidal shape may be imparted to the thrombectomy catheter 12. Insuch a case, at least a portion of the guide catheter 100 between theproximal and distal balloons 106 and 108 will be flexible enough to takethe sinusoidal shape when the thrombectomy catheter 12 is inserted intothe guide catheter 100.

As shown in FIG. 12, the guide catheter 100 includes a series ofopenings 120 a-120 d positioned about the catheter to provide access toa vessel lumen from within the guide catheter 100.

In use, the guide catheter 100 may be positioned within a vessel lumenusing standard placement techniques (such as using a guidewire) suchthat the occlusive material is positioned between the proximal balloon106 and the distal balloon 108. The balloons 106 and 108 can be inflatedto confine the occlusive material between the balloons within the vessellumen. Thereafter, if desired, a thrombolytic agent such as tPA can beinfused into the vessel lumen through the additional lumen (not shown)provided in the guide catheter to treat the occlusive materialchemically. Although the thrombolytic agent could be delivered into thevessel lumen through different passages of the guide catheter, it isbeneficial to infuse the thrombolytic agent through a passage of smallerdiameter such that the thrombolytic agent is directed against theocclusive material with velocity.

After the occlusive material has been treated with thrombolytic agent,the thrombectomy catheter 12 can be inserted through the guide catheter100. As illustrated in FIG. 11, preferably the thrombectomy catheter 12is positioned within the guide catheter 100 at a position spaced adistance “D” from a crest “C” of the sinusoidal shape. Since the crest“C” of the sinusoidal shape will be positioned adjacent a wall of thevessel 102, spacing the distal end of the thrombectomy catheter 12 adistance “D” away from the crest “C” minimizes the likelihood that thewall of the vessel 102 will be drawn into the fluid jet 50 (FIG. 5)further maximizing safety of the device. After the thrombectomy catheter12 is properly positioned within the guide catheter 100, thethrombectomy catheter 12 can be operated in the manner discussed aboveto remove additional occlusive material from the vessel 102.

It is envisioned that the guide catheter 100 and thrombectomy catheter12 can be used together without first infusing a thrombolytic agentthrough the guide catheter. It is further envisioned that thethrombolytic agent can be infused into the vessel 102 through thethrombectomy catheter 12, such as through the infusion lumen 32 of thecatheter body 24.

FIGS. 13 AND 14 illustrate alternate embodiments of the presentlydisclosed thrombectomy catheter shown generally as 212 (FIGS. 13) and312 (FIG. 14). Catheters 212 and 312 are substantially similar tocatheter 12 except that the high pressure tube 228, 328 is configured todirect a high pressure jet 250, 350 into the exhaust lumen 230, 330 ofthe catheter in a direction at an angle to the longitudinal axis of thecatheter. More specifically, catheter 212 includes a high pressure tube228 which has a nozzle orifice which directs the high pressure jet 250along an axis J which defines an angle β of between about 15 degrees andabout 75 degrees with respect to the longitudinal axis K of the catheter212. In one embodiment, β is between about 30 degrees and about 60degrees and may be about 45 degrees. The configuration of catheter 212facilitates easier entry of the catheter 212 into the occlusivematerial.

Referring to FIG. 14, the catheter 312 includes a high pressure tube 328which includes a nozzle orifice which directs a high pressure jet 350along an axis J which defines an angle β of about 90 degrees withrespect to the longitudinal axis K of the catheter 312. Each ofcatheters 212 and 312 includes an infusion lumen which is not shownwhich is similar to the infusion lumen 32 included in catheter 12.

FIGS. 15 and 16 illustrate yet another alternate embodiment of thepresently disclosed thrombectomy catheter shown generally as 412.Catheter 412 includes an annular infusion lumen 432, a central exhaustlumen 430 and a high pressure supply tube 428. The supply tube 428includes a bent portion 440 defining a nozzle 440 a. The nozzle 440 a ispositioned to direct a jet 450 of fluid into a distal end of the exhaustlumen 430. As illustrated, the catheter 412 may be integrally formedwith the high pressure tube 428. Although not shown, a more rigid bentportion 440 may be provided at the distal end of high pressure tube 428to prevent deflection of the bent portion 440 caused by ejection of thejet 450.

FIGS. 17 and 18 illustrate yet another embodiment of the thrombectomycatheter shown generally as 512. Catheter 512 includes a catheter body524 defining an exhaust lumen 530, an infusion lumen 532, and a highpressure fluid supply lumen 528. A distal end of the high pressure fluidsupply lumen 528 includes a bent portion 540 having a nozzle orifice 540a. The nozzle orifice 540 a is positioned to direct a jet 550 of fluidinto the distal end of the exhaust lumen 530. As illustrated, theinfusion lumen 532 is centrally disposed in the catheter body 524 incontrast to infusion lumen 432 of catheter 412 which is positionedannularly about the catheter body 424.

Other than the different orientations and configurations of the variouslumens, the embodiments shown in FIGS. 15-18 would be constructed andoperate similar to the previous embodiments shown in FIGS. 1-8. Thevariations in the infusion lumens 432, 532, provide the ability to varythe angular coverage of the infusion lumens around the exhaust lumensanywhere between 0 and 360°. Further, the infusion lumen 532 shown inFIGS. 17-18 provide infusion directly adjacent the cutting jet 550.Maximizing the angular coverage ensures a means for maximizingrecirculation of infusion fluid, which in turn minimizes the amount ofblood aspirated from the body lumen.

FIG. 19 illustrates an alternate embodiment of the presently disclosedthrombectomy catheter shown generally as 612. Catheter 612 is similar tocatheter 12 and includes a catheter body 624 defining an exhaust lumen630, an infusion lumen 632 and a high pressure fluid supply lumen 628. Adistal end of the high pressure fluid supply lumen 628 includes a bentportion 640 having a nozzle orifice 640 a. The nozzle orifice 640 a ispositioned to direct high pressure fluid into the exhaust lumen 630.

The exhaust lumen 630 includes a dividing wall 660 that divides theexhaust lumen 630 into first and second exhaust lumen sections 630 a and630 b. First exhaust lumen section 630 a includes a channel 662 whichenables a portion of the fluid aspirated into the first exhaust lumensection 630 a to be recirculated into a body lumen in the directionindicated by arrows “X”. A filter 666 is provided at the inlet to thefirst exhaust lumen section 630 a to prevent passage of solid particles,such as occlusive material and solid blood components, into the firstexhaust lumen section 630 a. In one embodiment, the filter 666 ispositioned at angle to direct the solid particles filtered from fluidentering the first exhaust lumen section 630 a into the second exhaustlumen section 630 b. The proximal end of each of the exhaust lumensections 630 a and 630 b communicate with an exhaust reservoir, such asreservoir 18, as discussed above with respect to system 10 shown in FIG.1.

In another embodiment of the presently disclosed thrombectomy catheter,shown generally as 712 in FIG. 20, a second recirculation channel 770 isprovided, as will be discussed in further detail below. Catheter 712includes a body 724 defining an exhaust lumen 730, an infusion lumen(not shown) and a high pressure fluid supply lumen 728 which includes abent portion 740 having a nozzle orifice 740 a. The exhaust lumen 730includes a dividing wall 760 which divides the exhaust lumen 730 intofirst and second exhaust lumen sections 730 a and 730 b. A first filter766 is positioned in the distal end of the first exhaust lumen section730 a. The first filter 766 is similar to the filter 666 and preventssolid particles from passing into the first exhaust lumen section 730 aand passing through the recirculation channel 762. The recirculationchannel 762 enables a portion of the fluid entering the first exhaustlumen section 730 a to enter back into the lumen of a patient. Thecatheter 712 differs from the catheter 612 in that filter 766 is notangled but extends across the first exhaust lumen section 730 a(although the filter 766 may be angled), and in that the secondrecirculation channel 770 recirculates a portion of the fluid exitingthe second exhaust lumen section 730 b into high pressure fluid supplylumen 728. A second filter 772 is positioned within recirculationchannel 770. In one embodiment, the second filter 772 has a mesh sizewhich permits fluids and very small solid particles, for example, lessthan 0.0005 inches, to pass into supply lumen 728. More specifically,the solid particles should be at least an order of magnitude less insize than the nozzle orifice diameter. By enabling small solid particlesto pass into the high pressure supply lumen 728, a sand blasting-likeeffect can be achieved from nozzle 740 a to more effectively removeocclusive material from a body lumen. Although now shown, catheter 712may be provided with only one of recirculation channels 770 and 762. Inaddition, although it is disclosed to supply solid particles from theexhaust lumen 730 to the high pressure supply lumen 728, it isenvisioned that solid particles may be supplied to the high pressuresupply lumen 728 directly from the high pressure fluid source 16 (FIG.1).

FIG. 21 illustrates another embodiment of the presently disclosedthrombectomy catheter, shown generally as 812. The catheter 812 includesa catheter body 824 defining an exhaust lumen 830 and an infusion lumen832 and having a high pressure fluid supply lumen 828. The high pressurefluid supply lumen 828 includes a bent portion 840 having a nozzleorifice 840 a positioned to direct high pressure fluid into the exhaustlumen 830.

The thrombectomy catheter 812 includes macerating structure 876 in theexhaust lumen 830 for breaking up the occlusive material. This may helpprevent clogging of the exhaust lumen 830 by the occlusive material. Themacerating structure 876 may include a component having sharp cuttingedges, such as a grate or perforated plate, which is positioned to breakup occlusive material which is aspirated into the exhaust lumen 830.Alternatively, the macerating structure 876 may assume a variety ofconfigurations including a rotatable turbine or grinder which rotates inresponse to fluid flow through the exhaust lumen 830, or a series ofabrasive projections positioned within or along the walls of exhaustlumen 830.

FIG. 22 illustrates yet another embodiment of the presently disclosedthrombectomy catheter shown generally as thrombectomy catheter 912.Thrombectomy catheter 912 includes a catheter body 924 defining anexhaust lumen 930 and an infusion lumen 932 and having a high pressurefluid supply lumen 928 including a bent portion 940 and a nozzle 940 a.An atraumatic tip 960 is positioned about the distal end of thrombectomycatheter 912 and defines a window 980 between nozzle 940 a and the inletto exhaust lumen 930. A separator 982, such as a cage or screenstructure, is positioned over the window 980. The separator 982minimizes the amount tissue which will be drawn into the cutting window980 to minimize the likelihood of damage to a vessel wall caused by thevessel wall coming into contact with the fluid jet 950. Although notshown, the separator 982 can be slidably positioned about or withincatheter 912 such that the separator 982 can be selectively positionedover window 980 or moved away from window 980.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. It is envisioned thatthe elements and features illustrated or described in connection withone exemplary embodiment may be combined with the elements and featuresof another exemplary embodiment without departing from the scope of thepresent disclosure. For example, the sensors 80 a-80 c which aredescribed with respect to thrombectomy catheter 12 shown in FIG. 2 canbe incorporated into any of the thrombectomy catheters described hereinAs well, one skilled in the art will appreciate further features andadvantages of the disclosure based on the above-described embodiments.Accordingly, the disclosure is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims.

1-20. (canceled)
 21. A thrombectomy catheter system comprising: acatheter including a catheter body and a high pressure tube, thecatheter body defining an exhaust lumen and an infusion lumen, and thehigh pressure tube having a nozzle orifice positioned to direct a fluidjet into a distal opening of the exhaust lumen; a source of infusionfluid communicating with a proximal end of the infusion lumen; a fluidcontrol device fluidly coupled between the catheter and the source ofinfusion fluid, the fluid control device being adapted to regulate aflow rate of infusion fluid from the source of infusion fluid to theinfusion lumen of the catheter, wherein the high pressure tube extendsthrough the infusion lumen of the catheter body; and a recirculationchannel configured to recirculate fluid from the exhaust lumen and intoone of a body lumen of a patient or the high pressure tube.
 22. Thethrombectomy catheter system according to claim 21, wherein therecirculation channel is positioned to recirculate fluid from within theexhaust lumen back into the body lumen of the patient.
 23. Thethrombectomy catheter system according to claim 22, further including afilter positioned upstream of the recirculation channel, the filterbeing sized to prevent passage of solid particles into the recirculationchannel.
 24. The thrombectomy catheter system according to claim 23,wherein the exhaust lumen is divided into a first exhaust lumen sectionand a second exhaust lumen section by a dividing wall, and wherein thefilter and the recirculation channel are positioned in the first exhaustlumen section.
 25. The thrombectomy catheter system according to claim24, wherein the filter is positioned at one end of the first exhaustlumen section and is angled to direct solid particles into the secondexhaust lumen section.
 26. The thrombectomy catheter system according toclaim 21, wherein the recirculation channel extends between the exhaustlumen and the high pressure tube.
 27. The thrombectomy catheter systemaccording to claim 26, further comprising a filter disposed in therecirculation channel, wherein the filter is configured to enable smallsolid particles to enter the high pressure tube.
 28. The thrombectomycatheter system according to claim 27, wherein the filter is configuredto pass solid particles having a first diameter at least an order ofmagnitude smaller than a second diameter of the nozzle orifice.
 29. Thethrombectomy catheter system according to claim 21, wherein the highpressure tube defines a high pressure fluid supply lumen separate fromthe infusion lumen, wherein the infusion lumen delivers the infusionfluid through an opening different from the nozzle orifice of the highpressure tube, and wherein the infusion opening is different from thedistal opening of the exhaust lumen.
 30. The thrombectomy cathetersystem according to claim 21, wherein the infusion fluid and fluid inthe high pressure tube is selected from the group consisting of saline,a thrombolytic agent, a contrast medium, and combinations thereof. 31.The thrombectomy catheter system according to claim 21, wherein a distalportion of the high pressure tube defines a bent portion, the nozzleorifice being positioned in the bent portion.
 32. The thrombectomycatheter system according to claim 30, wherein the bent portion extendsalong an axis which is substantially transverse to a longitudinal axisof the catheter.
 33. The thrombectomy catheter system according to claim21, further comprising a source of high pressure fluid communicatingwith the high pressure tube.
 34. The thrombectomy catheter systemaccording to claim 21, wherein the exhaust lumen is a first exhaustlumen and the infusion lumen is a first infusion lumen, furthercomprising a positioning band secured to a distal end of the catheterbody, the positioning band defining a second exhaust lumen whichcommunicates with the first exhaust lumen of the catheter body and asecond infusion lumen which communicates with the first infusion lumenof the catheter body.
 35. The thrombectomy catheter system according toclaim 21, wherein: the catheter further comprises an atraumatic tipsecured to the catheter body, the infusion lumen is a first infusionlumen, and the atraumatic tip comprises a pair of infusion channels anda central cavity, the infusion channels being in communication with asecond infusion lumen of the positioning band, and the central cavityconfigured to receive a distal portion of the high pressure tube, andthe central cavity having an upper opening.
 36. The thrombectomycatheter system according to claim 21, further comprising a guidecatheter defining a guide lumen dimensioned to receive the thrombectomycatheter, a proximal balloon, and a distal balloon.
 37. The thrombectomycatheter system according to claim 21, further comprising a sensorconfigured to measure the pressure within a body lumen of the patient,and wherein fluid control device is configured to be fluidly connectedto the infusion lumen and operable to control, based on the measuredpressure from the sensor, a flow rate of the infusion fluid through theinfusion lumen.
 38. A thrombectomy catheter system comprising: acatheter including a catheter body and a high pressure tube, thecatheter body defining an exhaust lumen and an infusion lumen, and thehigh pressure tube having a nozzle orifice positioned to direct a fluidjet into a distal opening of the exhaust lumen; a source of infusionfluid communicating with a proximal end of the infusion lumen; a fluidcontrol device fluidly coupled between the catheter and the source ofinfusion fluid, the fluid control device being adapted to regulate aflow rate of infusion fluid from the source of infusion fluid to theinfusion lumen of the catheter, wherein the high pressure tube extendsthrough the infusion lumen of the catheter body; and means forrecirculating fluid from the exhaust lumen and into one of a body lumenof a patient or the high pressure tube.
 39. The thrombectomy cathetersystem according to claim 38, wherein the means for recirculating fluidcomprises means for recirculating fluid from within the exhaust lumenback into the body lumen of the patient.
 40. The thrombectomy cathetersystem according to claim 38, wherein the means for recirculating fluidcomprises means for recirculating fluid from the exhaust lumen and tothe high pressure tube.